Fluid mixing control device for a multi-fluid delivery system

ABSTRACT

The control device is used to control delivery of fluids from a multi-fluid delivery system during a medical injection procedure. The fluid delivery system includes an injector used to deliver injection fluids to a patient. The control device is operatively associated with the injector for controlling discrete flow rates of injection fluids delivered to the patient. The control device includes first and second actuators associated with the manual control device, and an electronic substrate disposed within the manual control device and having a conductive pattern. The first actuator is operatively associated with the conductive pattern. The conductive pattern includes a plurality of predetermined digital values corresponding to discrete flow rates of injection fluids to be delivered by the injector. The second actuator is operatively associated with the electronic substrate and initiates output signals to the injector corresponding to desired mixture ratios of the injection fluids to be delivered by the injector.

RELATED APPLICATIONS

The present application is a continuation application from U.S. patentapplication Ser. No. 14/687,297, filed Apr. 15, 2015, now U.S. Pat. No.9,861,742, which is a continuation application from U.S. patentapplication Ser. No. 12/265,060, filed Nov. 5, 2008, now U.S. Pat. No.9,011,377, the disclosures of which are incorporated by this reference.The present application incorporates by reference U.S. patentapplication Ser. No. 11/085,616, filed Mar. 21, 2005, now U.S. Pat. No.7,879,008, and U.S. patent application Ser. No. 11/928,021, filed Oct.30, 2007, now U.S. Pat. No. 7,766,883, the disclosures of which areincorporated herein by reference in their entirety

BACKGROUND Field of the Disclosure

The present disclosure relates generally to control devices forcontrolling operation of fluid-supplying machines or apparatus used inmedical procedures such as angiography and, further, to hand-heldcontrol devices for controlling the flow rate of fluids, such ascontrast media and/or common flushing agents, injected into a patientduring medical procedures, such as angiography.

Description of Related Art

Angiography is a procedure used in the detection and treatment ofabnormalities or restrictions in blood vessels. During angiography, aradiographic image of a vascular structure (i.e., blood vessel) isobtained by injecting radiographic contrast material, also referred toas contrast media, through a catheter into a vein or artery. X-rays arepassed through the region of the body in which the contrast media isconcentrated. The X-rays are absorbed by the contrast material, causinga radiographic outline or image of the blood vessel containing thecontrast media. The X-ray's images of the blood vessel filled with thecontrast media are usually recorded onto film or videotape and aredisplayed on a fluoroscope monitor.

Many angiographic procedures, in particular coronary angiography andespecially coronary vascular interventional procedures such asangioplasty, require frequent intermittent injections of contrast media.The contrast media is administered in varying volumes as well asmodulated strengths and time durations. The intermittent contrast mediainjections are critical for optimal positioning of guiding catheters atthe targeted blood vessels, positioning of guide wires to and throughthe targeted areas during catheter interventions (i.e., percutaneoustransluminal coronary angioplasty), and for assessment of the results ofsuch interventional procedures.

During angiography, after a physician places the angiographic catheterinto a vein or artery, the angiographic catheter is connected to eithera manual or an automatic contrast media injection mechanism. A typicalmanual contrast media injection mechanism includes a syringe and acatheter connection. The user of the manual contrast media injectionmechanism adjusts the rate and volume of injection by altering themanual actuation force applied to the plunger of the syringe.

Automatic contrast media injection mechanisms typically involve asyringe connected to a linear actuator. The linear actuator is connectedto a motor which is controlled electronically. The operator enters intothe electronic control a fixed volume of contrast media and a fixed rateof injection. There is typically no interactive control between theoperator and the mechanism, except to start or stop the injection. Achange in flow rate occurs by stopping the mechanism and resetting theparameters.

Recent improvements in the radiographic imaging field have attempted toapply software and hardware interfaces to automatic contrast mediainjection mechanisms to provide variable flow rate and fixed flow ratemodes to the operator. Additionally, the delivery of common flushingagents, such as saline, may also be controlled using thesoftware/hardware interfaces. One such angiographic control device isdisclosed in U.S. Pat. No. 5,515,851 to Goldstein. The Goldstein patentdiscloses the use of a microchip control device in the form of anangiographic control pad device designed to facilitate finger touchmodulation of flow rate, volume, and duration of contrast mediainjection into a patient during an angiographic procedure. The controlfinger pad device allows the operator to control the aforementionedparameters during an injection procedure by altering the duration andextent of fingertip depression on the finger pads.

Another control device used to provide variable flow rate control to anoperator of an automatic contrast media injection mechanism is disclosedin U.S. Pat. No. 5,916,165 to Duchon et al. This reference discloses ahand-held pneumatic control device that interfaces with and controls afluid supply or injection mechanism. The hand-held control device isfurther adapted to control dispensement of saline injected into thepatient during the angiographic procedure. The hand-held control deviceis generally adapted to be responsive to fluid pressure within thedevice. The control device includes a pressure control member adapted toselectively change fluid pressure within the pressure control memberbased on inputs from the operator. In one embodiment, the control deviceis provided with one or more internal air bladders having a volume thatselectively adjusts to change the fluid pressure within the air bladdersbased on operator inputs. Internal sensors are provided to monitor thevolume changes of the air bladders, and generate control signals basedon the volume changes.

U.S. Pat. No. 5,988,587, also to Duchon et al., discloses anotherversion of a hand-held control device for an automatic contrast mediainjection mechanism. This reference discloses a hand-held control devicethat includes two opposing and spaced-apart handles. A resilientattachment member connects the two handles. The resilient attachmentmember is configured to allow the first handle to move with respect tothe second handle in response to operator inputs. The control deviceincludes a sensor attached to the first handle for producing a variablecontrol signal indicative of the distance between the first handle andthe second handle.

Yet another hand-held control device is disclosed in U.S. Pat. No.6,221,045 to Duchon et al. This reference discloses a hand-held controldevice that generates a control signal that is continuously variableaccording to continuously varying movement of a user's hand on thehand-held control. The control signal is continuously variable andsustainable at any value between preset maximum and minimum valuescorresponding to maximum and minimum contrast media discharge flowrates.

It is also known that the concept of diluting contrast with saline isgaining in popularity in the medical imaging industry. Certain solutionsfor automating this process already exist. However, some known “mixing”solutions are somewhat low tech. They often involve mixing by hand ineither a sterile bowl or syringe. Prior art hand control devices in themarket today do not provide such a mixing capability. Further, futuregenerations of injector equipment that might permit mixing may belimited in that, once the injection is started, the mixture of contrastand saline cannot be adjusted.

As automatic contrast media/fluid injection mechanisms and systemsbecome more complex, it is desirable to interface with such mechanismsand systems on a digital level to afford more control over the medicalinjection procedures performed with such devices. The foregoing examplesof hand-held control devices provide a certain amount of control oversuch procedures by offering the operator of the contrast media/fluidinjection mechanism or system a variable flow rate mode of operating themechanism or system. However, there is room for improvement in the fieldof control devices for controlling or operating contrast media/fluidinjection mechanisms or systems, for example, by providing a controldevice that may interface with such mechanisms or systems on a trulydigital level, while providing accurate flow rate control of contrastmedia injection and/or saline flush control and, desirably, controlledmixing of contrast media and saline. Additionally, there is a need for ahand-held control device that is simple to use, for example, having anintuitive look and feel of operation for the operator. Further, a needexists for a hand-held control device that is simple and inexpensive tomanufacture, so that the device itself may be disposable after a presetnumber of uses.

BRIEF SUMMARY

Generally, a fluid delivery system is disclosed herein for use inmedical injection procedures that includes a control device forcontrolling flow rates of fluid delivered from the fluid delivery systemto a patient. The fluid delivery system typically includes an injector,for example, a powered injector for delivering fluid to the patient. Thecontrol device is generally adapted to control flow rates of fluiddelivered by the injector to the patient. In particular, the controldevice is adapted to provide a user of the control device with theability to vary the flow rates of fluid from the injector.

The fluid delivery system and control device may be used in medicalinjection procedures, such as angiography. In such procedures, asindicated previously, an injector, either manual or powered, is used todeliver fluids, particularly contrast media, under pressure to apatient. Typically, the patient is connected to a syringe associatedwith the injector by a catheter. The contrast media is injected into thepatient upon actuation of the injector. The disclosed control device isgenerally adapted to control the injection fluid flow rate to thepatient from the injector, for example, a powered injector. Thus, thecontrol device provides the operator of a powered injector with avariable flow rate mode to deliver contrast media at discrete flow ratesdesired by the operator, who is typically a medical practitioner.

Additionally, the control device is generally adapted to control thedelivery of additional injection fluids beyond contrast media. Forexample, it is common to supply saline to the patient during certainaspects of injection procedures, such as angiography. The control deviceis further adapted to start and stop the flow of an additional fluid,such as saline, to the patient when commanded by the user. If desired,the control device may be adapted to allow mixing of contrast media withflushing media. Such mixing may be real-time and the device may allowboth real-time variability of flow rate and variability of contrastmedia/saline mix (or of any two desired fluids). Such a mixing controldevice typically interfaces with a multi-axis or multi-fluidinjection/delivery system which receives and acts upon signals outputtedby the mixing control device.

Moreover, the control device may be configured to be hand-held and maybe ergonomically designed to fit comfortably within the human hand.Further, the control device may be provided as a disposable device,typically used for only a certain number of procedures before beingdiscarded.

A fluid delivery system according to one embodiment generally includesan injector that may be adapted to actuate a syringe used to deliver aninjection fluid to a patient, and a control device operativelyassociated with the injector, either directly or indirectly, forcontrolling flow rates of the injection fluid delivered to the patient.The control device generally includes a housing and an actuatorassociated with the housing. The control device further includes anelectronic substrate disposed within the housing. The electronicsubstrate comprises a conductive pattern, defined or formed thereon. Theactuator is adapted for operative association with the conductivepattern when actuated by a user. The conductive pattern may comprise aplurality of predetermined digital values corresponding to discrete flowrates of injection fluid to be delivered by the injector, such that whenthe actuator is actuated, the actuator operatively associates with theconductive pattern and transmits the digital values to the injector.

The actuator may be movably associated with the housing for operativelyassociating with the conductive pattern. The digital values may bearranged such that the discrete flow rates are linearly proportional todistance of movement of the actuator. Additionally, the digital valuesmay be arranged such that the discrete flow rates incrementally increasewith distance of movement of the actuator. The incremental increase maycomprise 5%, 10%, 20%, or any desired incremental increase with eachdigital value. The digital values typically include at least a firstdigital value corresponding to no movement of the actuator and a 0%(i.e., no) discrete flow rate, and a last digital value corresponding toa maximum movement of the actuator and a 100% (i.e., full) discrete flowrate. The last digital value may correspond to a maximum possible flowrate from the injector.

The actuator may be movably associated with the housing for operativelyassociating with the conductive pattern. The actuator may comprise anactuating member and a contact adapted to operatively associate with theconductive pattern. The contact may be in the form of a contact rolleradapted to operatively associate with the conductive pattern. The rollermay be formed of electrically conductive resilient material and may bebiased into engagement with the electronic substrate. The contact mayalso be in the form of a contact plate having contact fingers adapted tooperatively associate with the conductive pattern. The actuating membermay be slidably associated with the electronic substrate.

The contact may be adapted to sequentially access the digital values ofthe conductive pattern when the actuating member is moved relative tothe housing. A biasing member may further be associated with theactuating member for biasing the actuating member to a neutral positionrelative to the housing. The biasing member may act on the actuatingmember such that the user of the control device experiences increasingtactile resistance as the actuating member is moved relative to thehousing. The biasing member may be further adapted to provide tactileresistance proportional to distance of movement of the actuator relativeto the housing.

The electronic substrate and/or housing may comprise sound producingstructures positioned to be engaged by the actuator for audiblyindicating movement of the actuator relative to the housing.

The control device may be operatively connected to the injector via afluid control module associated with the injector. The control devicemay further comprise a secondary actuator adapted to transmit asecondary fluid actuation signal to, for example, the fluid controlmodule upon actuation. The secondary actuator may comprise a controlbutton operatively associated with the electronic substrate forinitiating the secondary fluid actuation signal.

A data communication cable may be associated with the electronicsubstrate for transmitting the digital values to the injector, eitherdirectly or indirectly. The data communication cable may be adapted toremovably connect the control device with the injector, either directlyor indirectly.

The housing of the control device may be a multi-piece housing includingat least a first portion and a second portion. The first portion andsecond portion may be permanently joined together, for example, bondedtogether with an adhesive. The housing may be sized and shaped to behand-held. A disposable sheath may enclose the respective pieces orportions forming the housing of the control device.

Another embodiment of the fluid delivery system is adapted to delivermultiple injection fluids to a patient and the control device may beused to control such a multi-fluid delivery system during medicalprocedures. In this embodiment, the fluid delivery system includes aninjector for delivering multiple injection fluids to the patient. Thecontrol device is operatively associated with the injector and isadapted to control multi-fluid delivery from the multi-fluid deliverysystem. Accordingly, another embodiment of the control device generallycomprises a housing, a first actuator associated with the housing, anelectronic substrate disposed within the housing, and a second actuatorassociated with the housing and operatively associated with theelectronic substrate. The electronic substrate comprises a conductivepattern and the first actuator is adapted to operatively associate withthe conductive pattern when actuated by a user. The conductive patterncomprises a plurality of predetermined digital values corresponding todiscrete flow rates of the injection fluids to be delivered by theinjector desirably used in the multi-fluid delivery system such thatwhen the first actuator is actuated, the first actuator operativelyassociates with the conductive pattern and transmits the digital valuesto the injector. In use, actuation of the second actuator initiatesoutput signals to the injector desirably used in the multi-fluiddelivery system corresponding to desired mixture ratios of the injectionfluids to be delivered by the injector.

The first actuator may be movably associated with the housing foroperatively associating with the conductive pattern. The digital valuesmay be arranged such that the discrete flow rates are linearlyproportional to distance of movement of the first actuator.Additionally, the digital values may be arranged such that the discreteflow rates incrementally increase with distance of movement of the firstactuator. The incremental increase may comprise 5%, 10%, 20%, or anydesired incremental increase with each digital value. The digital valuestypically include at least a first digital value corresponding to nomovement of the first actuator and a 0% (i.e., no) discrete flow rate,and a last digital value corresponding to a maximum movement of thefirst actuator and a 100% (i.e., full) discrete flow rate. The lastdigital value may correspond to a maximum possible flow rate from theinjector. The first actuator may comprise an actuating member and acontact roller adapted to operatively associate with the conductivepattern.

The second actuator may comprise a potentiometer, such as a linearpotentiometer or a rotational potentiometer. Alternatively, the secondactuator may comprise at least one push button. A second electronicsubstrate may be disposed within the housing and comprise a conductivepattern. The second actuator may be adapted to operatively associatewith the conductive pattern on the second electronic substrate whenactuated by the user. The fluid second actuator may also be movablyassociated with the housing and comprise an actuating member and acontact roller adapted to operatively associate with the conductivepattern on the second electronic substrate.

A method of controlling a fluid delivery system using the control devicedescribed generally hereinabove is also described in detail herein. Themethod may include operatively connecting the control device to theinjector, with the control device adapted to control discrete flow ratesof the injection fluid to be delivered by the injector to the patientand actuating the control device to transmit one or more predetermineddigital values to the injector to control the discrete flow rates of theinjection fluid delivered by the injector.

The control device, as indicated previously, may include an actuator andan electronic substrate comprising a conductive pattern. The actuatormay be adapted for operative association with the conductive pattern andthe conductive pattern may comprise a plurality of predetermined digitalvalues corresponding to the discrete flow rates of the injection fluidto be delivered by the injector, such that the step of actuating thecontrol device may comprise the actuator operatively associating withthe conductive pattern to transmit one or more predetermined digitalvalues to the injector.

The actuator may be movable relative to the conductive pattern, suchthat the step of actuating the control device may comprise moving theactuator relative to the conductive pattern. The actuator may comprise acontact operatively associated with the conductive pattern, such thatwhen the actuator is moved relative to the conductive pattern thecontact operatively contacts the conductive pattern. The contact maysequentially access the digital values when the actuator is movedrelative to the conductive pattern. The contact may operatively contactthe conductive pattern by rolling along the surface of the conductivepattern. The method may further comprise audibly indicating movement ofthe actuator relative to the conductive pattern.

The method may further comprise discontinuing actuation of the controldevice, for example, by releasing the actuator, such that the biasingmember returns the actuator to a substantially pre-actuated positionrelative to the conductive pattern.

Furthermore, the control device may further comprise a secondaryactuator adapted to transmit a secondary fluid actuation signal to thefluid delivery system, and the method may further comprise actuating thesecondary actuator to transmit the secondary fluid actuation signal.

A variation of the method relates to controlling a multi-fluid deliverysystem comprising an injector in one example. In the alternative method,the method steps include operatively connecting a control device to theinjector, with the control device adapted to control discrete flow ratesof injection fluids to be delivered by the injector to a patient.Actuating a first actuator associated with the control device desirablytransmits one or more predetermined digital values to the injector tocontrol the discrete flow rates of the injection fluids delivered by theinjector. Actuating a second actuator associated with the control devicedesirably initiates output signals to the injector corresponding todesired mixture ratios of the injection fluids to be delivered by theinjector.

As noted in the foregoing, the control device desirably comprises anelectronic substrate comprising a conductive pattern and the firstactuator may be adapted for operative association with the conductivepattern. The conductive pattern, as noted, comprises, for example, aplurality of predetermined digital values corresponding to the discreteflow rates of the injection fluids to be delivered by the injector.Thus, the step of actuating the first actuator may comprise the firstactuator operatively associating with the conductive pattern to transmitone or more predetermined digital values to the injector. As furthernoted in the foregoing, the first actuator may comprise a contactoperatively associated with the conductive pattern, such that when thefirst actuator is moved relative to the conductive pattern the contactoperatively contacts the conductive pattern. The contact may operativelycontact the conductive pattern by rolling along the surface of theconductive pattern. The contact may sequentially access the digitalvalues when the first actuator is moved relative to the conductivepattern.

Moreover, as also noted in the foregoing, a second electronic substratemay be disposed within the housing and comprise a conductive pattern.The second actuator may be operatively associated with the conductivepattern on the second electronic substrate during the step of actuatingthe second actuator. As an example, the contact may operatively contactthe conductive pattern by rolling along the surface of the conductivepattern. Movement of at least one of the first actuator and the secondactuator may be alerted to a user via a sensory indication, for example,tactile, visual, and/or auditory indications.

Further details and advantages will become clear when reading thefollowing detailed description in conjunction with the accompanyingdrawings, wherein like reference numerals represent like elementsthroughout.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is perspective view of a control device in accordance with oneembodiment.

FIG. 2 is an exploded perspective view of the control device of FIG. 1.

FIG. 3 is a side view of a housing of the control device of FIGS. 1 and2.

FIG. 4 is a perspective view of a fluid delivery system incorporatingthe control device of FIGS. 1 and 2.

FIG. 5 is an exploded perspective view of an alternative embodiment ofthe control device.

FIG. 6 is a left side and partial cross-sectional view of the assembledcontrol device of FIG. 5.

FIG. 7 is a perspective view of a bottom portion of an actuator of thecontrol device of FIG. 5.

FIG. 8 is a perspective view of the bottom portion of the actuator ofFIG. 5, showing a contact roller of the actuator.

FIG. 9 is a detail and partial cross-sectional view of detail 9 in FIG.6.

FIG. 10A is a perspective view of an embodiment of a control deviceadapted to control the mixing of multiple fluids and showing right sideinternal details thereof.

FIG. 10B is a perspective view of the control device of FIG. 10A showingleft side internal details thereof.

FIG. 10C is an exploded perspective view of the control device of FIG.10A.

FIG. 11A is a perspective view of a second embodiment of a mixingcontrol device and showing right side internal details thereof.

FIG. 11B is a perspective view of the mixing control device of FIG. 11Ashowing left side internal details thereof.

FIG. 11C is an exploded perspective view of the mixing control device ofFIGS. 11A-11B.

FIG. 12A is a perspective view of a third embodiment of a mixing controldevice and showing right side internal details thereof.

FIG. 12B is a perspective view of the mixing control device of FIG. 12Ashowing left side internal details thereof.

FIG. 12C is an exploded perspective view of the mixing control device ofFIGS. 12A-12B.

FIG. 13A is a perspective view of a fourth embodiment of a mixingcontrol device and showing right side internal details thereof.

FIG. 13B is a perspective view of the mixing control device of FIG. 13Ashowing left side internal details thereof.

FIG. 13C is an exploded perspective view of the mixing control device ofFIGS. 13A-13B.

FIG. 14 is a perspective view of a fluid delivery system incorporatingmultiple syringes and which illustrates use of a mixing control deviceas found in FIGS. 10-13.

DETAILED DESCRIPTION

For purposes of the description hereinafter, spatial or directionalterms, if used, relate to the embodiment, as it is oriented in thedrawing figures. However, it is to be understood that the disclosure mayassume various alternative variations, except where expressly specifiedto the contrary. It is also to be understood that the specific apparatusillustrated in the attached drawings, and described in the followingdescription, are simply exemplary embodiments of the disclosure. Hence,specific dimensions and other physical characteristics related to theembodiments disclosed herein are not to be considered limiting.

A control device 10 according to one embodiment is illustrated in FIGS.1 and 2. The control device 10 is desirably configured to be hand-held,and may be referred to herein as “hand controller 10”. However, thisform of the control device 10 is merely exemplary, and the handcontroller 10 may be provided as a foot-controller or a robotic actuateddevice, as examples, or simply as an electronic console with one or moreactuating devices, such as buttons, joysticks, and like elements.

The hand controller 10 is intended for use with an automatic fluidinjection or delivery system 100, such as that generally illustrated inFIG. 4 discussed herein. The fluid delivery system 100 is used todeliver fluids to a patient during a medical injection procedure. Forexample, the fluid delivery system 100 may be used during anangiographic procedure to inject contrast media and common flushingagents, such as saline, into the body of a patient. An example of such afluid injection or delivery system is disclosed in U.S. patentapplication Ser. No. 09/982,518, filed on Oct. 18, 2001, assigned to theassignee of the present application, the disclosure of which isincorporated herein by reference in its entirety. An additional exampleis disclosed in U.S. patent application Ser. No. 10/825,866, filed onApr. 16, 2004, and entitled “Fluid Delivery System, Fluid ControlDevice, and Methods Associated with the Fluid Delivery System and FluidControl Device”, the disclosure of which is incorporated herein byreference in its entirety. The hand controller 10 is generally adaptedto interface with one or more components of the fluid delivery system100 to control the flow rates of the fluids, particularly contrast mediain the case of angiographic procedures, to be delivered to the patient.

The hand controller 10 is generally adapted for electrical connectionwith the fluid delivery system 100 and controls the fluid deliverysystem 100 once the fluid delivery system 100 is appropriatelyprogrammed to accept input commands from the hand controller 10. Moreparticularly, the hand controller 10 is adapted to digitally interfacewith the fluid delivery system 100 once associated therewith to deliverinput commands to the fluid delivery system 100.

The hand controller 10 is further generally adapted to receive discretephysical inputs from a user or operator, select a predetermined digitalvalue associated with each discrete physical input, and transmit theselected digital value to the fluid delivery system 100. Thepredetermined digital values or commands transmitted to the fluiddelivery system 100 are converted into specific or discrete flow rateoutputs from the fluid delivery system 100 which are delivered to thepatient. Preferably, the digital values are proportional, for example,linearly proportional, to the user's physical inputs. The patient may beconnected to the fluid delivery system 100 by means customary in themedical field, such as with a catheter.

With general reference to FIG. 1, the externally visible components ofthe hand controller 10 generally include a housing 12, an actuator 14associated with the housing 12, a secondary actuator 15 also associatedwith the housing 12, and a cable 16 extending from the housing 12. Theplacement of these and any other components of the hand controller 10are with reference to the presently illustrated embodiment and shouldnot be construed as limiting.

Generally, the actuator 14 and the secondary actuator 15 are disposed ata top end 17 of the housing 12, and the cable 16 extends from a bottomend 18 of the housing 12. The housing 12 may have an ergonomic shape, sothat the hand controller 10 may be comfortably held in either the leftor right hand by a user, and to allow for single-handed operationthereof, as generally disclosed in U.S. patent application Ser. No.10/237,139, filed on Sep. 6, 2002, assigned to the same assignee as thepresent application, the disclosure of which is incorporated herein inits entirety.

The housing 12 is desirably formed of plastic material, such as asuitable medical-grade plastic material. Inexpensive materials may beused for the housing 12 and the other components of the hand controller10 to be discussed herein, so that the hand controller 10 may be adisposable item, disposed of, for example, after a preset number ofprocedures are conducted using the fluid delivery system 100. Thehousing 12 is formed to enclose and support the internal components ofthe hand controller 10 to be discussed herein. The hand controller 10weighs in the range of about 0.25 to 1 pound, so that the handcontroller 10 may be comfortably manipulated by an operator for extendedperiods of time without fatigue.

The cable 16 is generally adapted to transmit input commands in the formof digital values from the hand controller 10 to the fluid deliverysystem 100. The cable 16 may be any suitable type of cable adapted todigitally transfer the digital values to the fluid delivery system 100.For example, the cable 16 may be any suitable multiple-strand wiringcable, such as 6-pin phone cable. The cable 16 terminates in a connector19 which is adapted to operatively and removably associate the handcontroller 10 with the fluid delivery system 100. The connector 19 maybe, for example, an RJ11 connector with six contacts which allows theend of the cable 16 distal or remote from the hand controller 10 to havea positive locking electrical connection with a component of the fluiddelivery system 100.

With reference to FIGS. 1 and 2, the internal components of the handcontroller 10 will now be discussed. The housing 12 includes at least afirst portion and a second portion, such as a left side or portion 20and a right side or portion 22, respectively. However, the housing 12may include any number of pieces or components and is generally intendedto be a multi-piece structure. The housing portions 20, 22 may includeone or more internal rib structures 23 that provide structural supportto the housing portions 20, 22, and support locations for supportingvarious internal components of the hand controller 10, as discussedherein. Since the hand controller 10 may be provided as a disposabledevice, as indicated previously, the housing portions 20, 22 may bepermanently secured together with an adhesive bond or a permanentmechanical seal once the internal components of the hand controller 10are assembled in place within the housing 12. Alternatively, the housingportions 20, 22 may be removably secured together by conventionalmechanical fasteners (not shown). The housing portions 20, 22 aredesirably formed of plastic material, for example, a suitablemedical-grade plastic material. Any inexpensive plastic or non-plasticmaterial may be used for the housing portions 20, 22, furtherfacilitating the disposability of the hand controller 10.

The hand controller 10 further includes, internal to the housing 12, anelectronic substrate 24, generally used to store the digital values tobe transmitted via the cable 16 to the fluid delivery system 100. Theelectronic substrate 24 may be a conventional printed circuit board andis generally a rectangular structure that defines opposing top andbottom holes 25. The electronic substrate 24 is secured to bosses 26integrally formed with the housing portion 22 of the housing 12 withconventional mechanical fasteners, such as screws 27 and washers 28. Thebody of the electronic substrate 24 defines one or more wire holes 29for receiving one or more corresponding wires 30 of the cable 16therein. The connection of the wires 30 with the wire holes 29 provideselectrical connection and electronic data communication between theelectronic substrate 24 and the fluid delivery system 100, once theconnector 19 at the end of the cable 16 is connected to a component ofthe fluid delivery system 100. The electronic substrate 24 includes atleast an equal number of wire holes 29 to the number of wires 30 in thecable 16.

Additionally, the electronic substrate 24 generally includes anelectrical contact arrangement or conductive pattern 32 thereon. Theconductive pattern 32 generally stores the digital values to betransmitted to the fluid delivery system 100. The digital values are inthe form of binary values that generally correspond to specific ordiscrete flow rates to be delivered by the fluid delivery system 100when the hand controller 10 is actuated, as discussed herein.

Generally, the conductive pattern 32, also referred to as a bit mapherein, includes a plurality of columns, such as columns 34 a-e, whereineach of the columns 34 a-e includes at least one electrical contact andan adjoining space. Column 34 a is a continual electrical ground contactand has no spaces. Thus, each of the columns 34 b-e includes acombination of electrical contacts and spaces representing bit values,(i.e., 1 or 0). For example, from a top to bottom orientation in FIG. 2,column 34 b includes an electrical contact, followed by a space, thenfollowed by another electrical contact, which is then followed by yetanother space, and finally, another electrical contact occupies thebottom of column 34 b. In contrast, column 34 d, for example, includes asingle electrical contact that is followed by a single space. As shownin FIG. 2, each electrical contact and space in each of the columns 34b-e may be of various lengths.

A collinear horizontal grouping (i.e., row) of the electrical contactsand spaces includes the combination of either an electrical contact or aspace from one or more of the columns 34 b-e and electrical groundcolumn 34 a, with another electrical contact or space from another ofthe columns 34 b-e. Thus, the conductive pattern 32 is generally dividedinto a plurality of collinear groupings (i.e., rows) of electricalcontacts and spaces or bit values. The bit values for each of thecolumns 34 b-e defines a specific “preprogrammed” digital or binaryvalue that is to be transmitted to the fluid control module 106 whenoperatively accessed by the actuator 14. Each collinear grouping (i.e.,row) corresponds to a predetermined gray code (i.e., a series of bitvalues). The predetermined or preprogrammed digital or binary values aredesirably linearly arranged within the conductive pattern 32 andrepresent corresponding discrete flow rates to be delivered from thefluid delivery system 100. More specifically, the predetermined orpreprogrammed digital or binary values within the conductive pattern 32(i.e., collinear rows taken from top to bottom) preferably correspond toincrementally increasing discrete fluid flow rates to be delivered fromthe fluid delivery system 100 when the actuator 14 is actuated, forexample, by the operator of the hand controller 10 moving the actuator14 relative to the housing 12 as discussed herein. The gray codeassociated with the conductive pattern 32, as it relates to the deliveryof flow rates from the fluid delivery system 100, may be generally asfollows in Table 1:

TABLE 1 Gray Code & Flow Rate Assignment Gray Code Flow Bit 3 Bit 2 Bit1 Bit 0 Rate 0 0 0 0 0% 0 0 0 1 10% 1 0 0 1 20% 1 1 0 1 30% 0 1 0 1 40%0 1 1 1 50% 0 0 1 1 60% 1 0 1 1 70% 1 0 1 0 80% 1 1 1 0 90% 0 1 1 0 100%0 = corresponding bit connected to ground. 1 = corresponding bit opencircuit.

The fluid delivery system 100 may utilize the foregoing gray code andthe predetermined digital or binary values associated therewith toincrementally control the flow rate of the injection fluid (i.e.,contrast media) in relation to a pre-programmed rate, such as 10 mL/s.For example, the predetermined digital or binary values may correspondto a predetermined volume per time rate, such as from 0 mL/s to the 10mL/s rate, or a predetermined percentage rate of the pre-programmedrate, such as 0% to 100% of the 10 mL/s rate.

As is known in the relevant art, gray code does not necessarily have asubsequent increasing binary value incremented by a bit value in theproper mathematically logical progression. Therefore, each subsequentcollinear grouping (i.e., row) of the conductive pattern 32 does notneed to conform to standard increasing binary value representation. Forexample, a flow rate of 0% may be represented by a collinear grouping(i.e., row) of four (4) electrical contacts (i.e., 0000) at the top ofthe conductive pattern 32. Immediately below this collinear grouping(i.e., row), the subsequent collinear grouping (i.e., row) may havethree electrical contacts followed by a single space (i.e., 0001), whichmay correspond to a flow rate of 10%. The next collinear grouping (i.e.,row), corresponding to a flow rate of 20%, may have a space followed bytwo electrical contacts, followed by another space (i.e., 1001). As theforegoing illustrates, the collinear groupings (i.e., rows) from the topto the bottom of the conductive pattern 32 do not necessarily correspondto standard increasing binary value representation which would normallyyield 0010 as the subsequent binary value for the 20% flow rate as anexample.

In the present embodiment, the conductive pattern 32 includes eleven(11) collinear groupings (i.e., rows) to represent flow rates rangingfrom 0% to 100%. The first collinear grouping (i.e., digital or binaryvalue) corresponds to no flow rate and the last collinear grouping(i.e., the 11^(th) row) corresponds to 100% or maximum flow rate whichmay be the maximum flow rate possible from the fluid delivery system 100or a preprogrammed maximum flow rate preprogrammed into or permitted bythe fluid delivery system 100. The respective digital or binary valuesprogrammed in the conductive pattern 32 are accessed by the actuator 14,the details of which are discussed herein. Generally, the actuator 14 ismovably associated with the housing 12, such that movement of theactuator 14 accesses the digital or binary values preprogrammed in theconductive pattern 32.

The electronic substrate 24 further includes sound producing structures36 that are desirably adapted to indicate when movement of the actuator14 has taken place. The sound producing structures 36 may be simplemechanical structures, such as ridges or grooves formed on theelectronic substrate 24 which are engaged by the actuator 14 when theactuator 14 is moved relative to the housing 12. The sound producingstructures 36 are generally disposed adjacent the conductive pattern 32,and may be arranged to correspond to the digital or binary valuespreprogrammed in the conductive pattern 32 (i.e., correspond to thecollinear groupings).

Alternatively, the mechanical sound producing structures 36 may bereplaced by an electronic sound producing device in generally the samelocation as the mechanical sound producing structures 36. The electronicsound producing device may be in the form of frequency modulators thatcorrespond, respectively, to the preprogrammed digital or binary valuesin the conductive pattern 32. As indicated, the mechanical soundproducing structures 36 or equivalent electronic sound producing deviceare configured to audibly indicate movement of the actuator 14. Theelectronic substrate 24 further includes a ground electrical contact 37that is in electrical contact with a corresponding ground wire of thecable 16.

The actuator 14 generally includes an actuating member 38, generally inthe form of a plunger which is movably associated with the housing 12and a contact 40 that is generally adapted to operatively associate withthe conductive pattern 32. The body of the actuating member 38 is formedwith a rod portion 41 and depending slide rails 42, 43. The end of therod portion 41 includes a finger pad 44 for the operator of the handcontroller 10 to place his or finger, thumb or palm (i.e., with twofingers under the flange portion of housing portions 20, 22) to actuatethe actuator 14. The slide rails 42, 43 are sufficiently spaced apart toslidably accommodate the electronic substrate 24 therebetween. Inparticular, the slide rails 42, 43 each define a guide track 45 forslidably receiving opposing lateral sides 241, 24 r of the electronicsubstrate 24 which enables the actuating member 38 to move up and downrelative to the electronic substrate 24. The opposing guide tracks 45defined by the respective slide rails 42, 43 preferably extend thelength of the slide rails 42, 43.

The contact 40 is secured to the actuating member 38 by mechanicalfasteners, such as screws 46 and cooperating washers 47. The screws 46cooperate with holes 48 defined in the contact 40 and, further, maycooperate in a friction fit manner with corresponding holes 49 definedin an attachment plate or flange 50 connected to the actuating member 38and generally extending between the slide rails 42, 43. The contact 40further includes a plurality of contact fingers 52 for contacting theconductive pattern 32 on the electronic substrate 24. The contactfingers 52 are adapted to contact the preprogrammed digital or binaryvalues (i.e., collinear groupings) on the electronic substrate 24.Generally, the actuator 14 accesses the preprogrammed digital or binaryvalues when an operator of the hand controller 10 engages and depressesthe finger pad 44 associated with the rod portion 41 which causes theactuating member 38 to depress into the housing 12. The contact 40 ofthe actuator 14 will progress sequentially from the first discretedigital or binary value (i.e., collinear grouping 1) to subsequentdiscrete digital or binary values (i.e. collinear groupings 2-11) as theoperator presses downward on the finger pad 44. The contact fingers 52establish the electrical connection with the respective digital orbinary values which are transmitted to the fluid delivery system 100 viathe cable 16. More specifically, the contact fingers 52 may contacteither an electrical contact or a space in each of the columns 34 b-e inthe conductive pattern 32.

A biasing assembly 54 is associated with the actuator 14, and isdisposed within the housing 12. The biasing assembly 54 is generallyadapted to bias the actuator 14 against movement relative to the housing12. The biasing assembly 54 is further adapted to provide increasingtactile resistance to the operator of the hand controller 10 the fartherthe actuating member 38 is moved (i.e., depressed into the housing 12).The biasing assembly 54 generally biases or tensions the rod portion 41upward away from the electronic substrate 24.

The biasing assembly 54 generally includes a mandrel 56 associated witha compression spring 58. However, it will be apparent that suitablemechanically equivalent structures may be used in place of the mandrel56 and compression spring 58 arrangement shown in FIG. 2, and discussedherein. The mandrel 56 generally has a first end 61 associated with thespring 58 and a second end 62 formed with an abutment flange 64. Theabutment flange 64 is generally adapted to engage a correspondingsurface or structure in the right portion 22 of the housing 12 whichwill allow the actuating member 38 to compress the spring 58 as theactuating member 38 is depressed into the housing 12 by the operator ofthe hand controller 10. For example, as shown in FIG. 2, one of the ribs23 in housing portion 22 of the housing 12 may be formed with anengagement ledge 65 against which the abutment flange 64 contacts orrests to allow the actuating member 38 to compress the spring 58 as theactuating member 38 is depressed into the housing 12. The engagementledge 65 may be recessed as illustrated in FIG. 2 to permit a matingengagement with the abutment flange 64.

The spring 58 is desirably configured such that the farther theactuating member 38 is depressed into the housing 12, the greaterbiasing force the operator of the hand controller 10 will experience.The first end 61 of the mandrel 56 is associated with the spring 58 anddesirably acts as a spring-guide to prevent buckling of the spring 58when the actuating member 38 is depressed.

The secondary actuator 15 is positioned generally adjacent the mainactuator 14 and is generally adapted to provide an actuation signal tothe fluid delivery system 100 to cause the fluid delivery system 100 todeliver a secondary injection fluid to the patient. Such a secondaryfluid may include saline supplied from a source of saline associatedwith the fluid delivery system 100. Saline is a common flushing agentused during medical injection procedures such as angiography. Thesecondary actuator 15 generally includes a control button 66 operativelyassociated with a switch 68 having leads 69 which are connected to theelectronic substrate 24, for example, by wires. The control button 66 isadapted for connection to housing portion 20 of the housing 12, such asby a pivotal connection therewith. The control button 66 is furthergenerally adapted to contact or engage with the switch 68 when thecontrol button 66 is depressed by the operator of the hand controller10. Two switch wires (not shown) may connect the leads 69 to the wiresholes 29 of the electronic substrate 24. Generally, when the operator ofthe hand controller 10 wants to initiate delivery of the secondaryinjection fluid, the operator depresses the control button 66 whichengages the switch 68. The switch 68 then initiates the actuation signalwhich is transmitted to the fluid delivery system 100 via the electronicsubstrate 24 and the cable 16.

With reference to FIGS. 2-4, one general method of assembling the handcontroller 10 will now be discussed. Initially, the secondary actuator15 may be assembled to the housing 12. This is accomplished byconnecting the control button 66 with the left portion 20 of the housing12 and positioning the switch 68 in a switch receiving pocket 70 definedby housing portion 20 of the housing 12. The switch receiving pocket 70is defined by the internal rib structures 23 in housing portion 20 ofthe housing 12. The leads 69 from the switch 68 may then be associatedwith the electronic substrate 24 by suitable wiring.

Next, the wires 30 of the cable 16 may be secured in the correspondingwire holes 29 in the electronic substrate 24. A portion of the cable 16will generally be retained within the right portion 22 of the housing12, generally behind the electronic substrate 24. A cable tie 71 may beused to secure this portion of the cable 16 to provide strain relief.The tied portion of the cable 16 to be retained in housing portion 22 ofthe housing 12 is located in a cavity 72 defined by housing portion 22of the housing 12. The electronic substrate 24 is used to secure thetied portion of the cable 16 when the electronic substrate 24 is securedto housing portion 22 of the housing 12 with screws 27 and washers 28.

The actuator 14 may be pre-assembled prior to being received in thehousing 12. The actuator 14 is generally assembled by connecting thecontact 40 to the attachment plate 50 extending between the slide rails42, 43 with the screws 46 and cooperating washers 47. Thereafter, thebiasing assembly 54 may be associated with the actuator 14. Inparticular, the compression spring 58 is placed about the mandrel 56 andthe first end 61 of the mandrel 56 is located between the slide rails42, 43, so that the compression spring 58 is in position to operativelyassociate with the actuating member 38. The slide rails 42, 43 generallydefine a receiving pocket 74 for the compression spring 58 and the firstend 61 of the mandrel 56.

The actuator 14 and biasing assembly 54 may be placed in housing portion22 of the housing 12 so that the abutment flange 64 on the mandrel 56contacts the engagement ledge 65 defined by one of the internal ribstructures 23 in housing portion 22. The actuator 14 is associated withthe electronic substrate 24 as the actuator 14 is assembled in housingportion 22 of the housing 12 by receiving the opposing sides 241, 24 rthereof in guide tracks 45 defined in the slide rails 42, 43. Theslidable engagement of the actuator 14 with the electronic substrate 24allows the contact 40 of the actuator 14 to operatively associate withthe conductive pattern 32. After applying a suitable adhesive to one orboth of housing portions 20, 22 of the housing 12, the housing portions20, 22 may be aligned, closed upon each other, and bonded together withadhesive or mechanical fastening.

With reference to FIGS. 1-4, the operation of the hand controller 10will now be discussed according to the above-discussed embodiment. Asindicated previously, the hand controller 10 is intended for use withthe automatic fluid delivery system 100 which is generally illustratedin FIG. 4. The fluid delivery system 100 generally includes a poweredinjector 102 that is adapted to support and actuate a syringe 104 usedto inject an injection fluid to a patient during a medical procedure,such as an angiographic procedure. The following operational discussionof the hand controller 10 will be with reference to an angiographicprocedure involving the fluid delivery system 100 and how the handcontroller 10 controls the delivery of the injection fluid from thefluid delivery system 100 to the patient. In typical angiographicprocedures, the injection fluid is contrast media and such procedurestypically further include saline as an additional or secondary injectionfluid or flushing agent that is supplied to the patient.

The injector 102 is operatively associated with a fluid control module106. The fluid control module 106 is generally adapted to support afluid path set 108 that is generally adapted to fluidly connect thesyringe 104 to a source of contrast media 109. The fluid path set 108further connects the syringe 104 to a catheter (not shown) which isassociated with the patient for supplying the contrast media and salineto the patient. The fluid path set 108 is further connected to a sourceof saline 110 which is supplied to the patient via the same catheter asthe contrast media. The contrast media flow from the syringe 104 and thesaline flow to the patient is regulated by the fluid control module 106which controls the various valves and flow regulating structures in thefluid path set 108 to regulate the delivery of contrast media and salineto the patient based on the digital values provided by the handcontroller 10. The hand controller 10 is shown connected to the fluidcontrol module 106 in FIG. 4. However, the hand controller 10 could alsobe connected directly with the injector 102. The injector 102 and thefluid control module 106 are desirably in electronic data communicationand the choice of associating the hand controller 10 with either theinjector 102 or the fluid control module 106 primarily depends on thecomputer hardware and software associated with the injector 102 and/orthe fluid control module 106. The injector 102 is generally used tosupply the contrast media under pressure to the fluid path set 108 and,ultimately, the patient. The injector 102 is controlled by the handcontroller 10 to supply the contrast media at discrete and preselectedflow rates based on the physical inputs to the hand controller 10, asindicated previously.

To use the hand controller 10 with the fluid delivery system 100, theoperator connects the cable 16 to the fluid control module 106 via theconnector 19 at the end of the cable 16. The fluid control module 106and injector 102 are programmed and set-up to receive input commandsfrom the hand controller 10. Once the hand controller 10 isappropriately placed in electronic data communication with the fluidcontrol module 106 and the injector 102 is appropriately primed withcontrast media and/or saline, the operator may actuate the handcontroller 10. It is assumed for the sake of expedience in explainingoperation of the hand controller 10 that all necessary steps have beenaccomplished to fill the syringe 104 with contrast media and place thesyringe 104 and the source of saline 110 in fluid communication with apatient via a catheter or other similar structure. Thus, the discussionherein regarding how the hand controller 10 controls the flow rate ofcontrast media and the supply of saline to the patient is with respectto an appropriately primed and programmed fluid delivery system 100.

To actuate the hand controller 10, the operator places his or herfinger, thumb, or palm on the finger pad 44 disposed at the end of therod portion 41 of the actuating member 38 of the actuator 14. As theactuating member 38 is depressed into the housing 12, the contact 40moves from an initial, preactuated position generally associated withthe first discrete digital or binary value in the conductive pattern 32to another discrete digital or binary value, such as the second digitalor binary value in the conductive pattern 32. The first discrete digitalor binary position corresponds to a flow rate of 0% from the injector102, and the second discrete digital or binary value corresponds, forexample, to an incrementally increased flow rate of 10% flow rate fromthe injector 102. When the contact 40 of the actuator 14 is in theinitial or preactuated position, the digital or binary value of 0% flowrate associated therewith is continuously transmitted to the fluidcontrol module 106 via the cable 16 and which interfaces electronicallywith the injector 102, for example, by relaying the digital or binaryvalue to the injector 102 which instructs the injector 102 not toactuate the syringe 104 and deliver fluid flow to the fluid path set108. The biasing assembly 54 is associated with the actuator 14 asdiscussed in previously, and biases the actuating member 38 toward theinitial or preactuated position, so that the initial or preactuatedposition of the actuating member 38 is the neutral or default positionfor the actuator 14, wherein no fluid flow is provided to the patient.Thus, if the operator for any reason discontinues pressure on the fingerpad 44, the actuator 14 will automatically return to the neutral ordefault position where flow of contrast media is immediatelydiscontinued.

When the contact 40 is in any other position with respect to theconductive pattern 32, the digital or binary value corresponding to thatposition is transmitted to the fluid control module 106 through thecable 16. It will generally be understood that as pressure is applied orreleased to the finger pad 44, the contact 40 will move freely up anddown in contact with the conductive pattern 32, and output the variousdigital or binary values in the conductive pattern 32 to the fluidcontrol module 106 which transmits the various digital or binary valuesas control signals to the injector 102. The injector 102 responds to thedigital or binary values by supplying the contrast media at specific,discrete flow rates corresponding to a received digital or binary valueuntil a new digital or binary values is received. Thus, the handcontroller 10 generally takes an operator's physical inputs and selectsor “looks up” a predetermined digital value associated with those inputsand digitally transmits the digital values to the injector 102 whichresponds to the digital values by delivering contrast media atpre-selected discrete flow rates corresponding to the digital values.

The hand controller 10 significantly improves over the prior art handcontrollers, discussed previously, because the prior art handcontrollers are limited to continuously converting user physical (i.e.,analog) inputs to digital outputs, without any means or method ofregulating or dampening the output from the injector. In practice, it isknown that even experienced operators of angiographic injectionapparatus may over-inject contrast media into a patient's body duringsuch procedures. In contrast, the hand controller 10 is adapted suchthat in each position of the physical structure used to make inputs tothe hand controller 10 (i.e., the actuator 14) the position directlycorresponds to a discrete digital value with no analog to digitalconversion required. As the operator makes physical inputs to theactuator 14, the injector 102 will respond with discrete, steppedchanges in flow rate which are more easily monitored and controlled bythe operator than the continuously variable flow rates provided by theprior art as shown and described, for example, in U.S. Pat. No.6,221,045. The prior art hand control devices discussed previously canlead to large swings in flow rates delivered to the patient, and thepossible over-delivery of contrast media.

At any time during the injection procedure, the operator may depress thesecondary actuator 15 to deliver a saline flush to the patient. Toinitiate the saline flush, the control button 66 is depressed whichinitiates an actuation signal, for example, a saline start signal.Specifically, when the control button 66 is depressed, the controlbutton 66 physically interacts with the switch 68 which initiates theactuation signal to the fluid control module 106. The actuation signalis transmitted via the electronic substrate 24 and the cable 16 to thefluid control module 106 which begins delivering saline from the sourceof saline 110 to the patient. If the primary actuator is actuated andthe secondary actuator is then actuated or vice versa, the injector 102will ignore the additional actuation. The secondary actuator 15 may beconfigured such that release of the control button 66 automaticallyceases delivery of saline to the patient. Alternatively, the secondaryactuator 15 may be configured such that a second depression of thecontrol button 66 again will transmit a fluid stop signal to the fluiddelivery system 100 which causes the fluid control module 106 to ceasedelivering saline.

It will generally be understood by those skilled in the art that thevarious signals transmitted by the hand controller 10 may be interpretedby the fluid control module 106 and/or injector 102 as either discreteflow or fixed flow signals depending on how the fluid control module 106and/or injector 102 are initially programmed. For example, the discreteflow signals may range from 0% to 100% of the preprogrammed flow rate.Alternatively, the fixed flow control signal may be 60% of thepreprogrammed flow rate, such that when the actuating member 38 is inany position past the initial or preactuated position a fixed flowsignal is automatically transmitted to the fluid delivery system 100.

In order to maintain sterility and prevent contamination, the handcontroller 10 may utilize a sterile sheath 80 (See FIG. 1), which isconfigured as a generally form-fittingly envelope enclosing at least thehousing 12 of the hand controller 10. The sterile sheath 80 may enclosethe actuator 14 and cable 16 as shown in dotted lines in FIG. 1. Thesterile sheath 80 may be transparent and is not intended to impair anyoperator functions of the hand controller 10. This optional sterilesheath 80 may be made of inexpensive material, desirably plastic, anddisposed after each use of the hand controller 10, extending the usable“disposable” life of the hand controller 10.

The hand controller 10, upon actuation of the actuator 14, generallyprovides a variety of physical and/or auditory cues for relaying to theoperator an indication that the hand controller 10 is operational. Inparticular, the hand controller 10 is adapted to indicate to theoperator the distance of movement or length of travel of the actuatingmember 38 within the housing 12 when the finger pad 44 is depressed bythe operator. The distance of movement of the actuating member 38 willintuitively tell the operator how fast the flow rate of contrast mediawill be and, consequently, how much contrast media is being delivered tothe patient by the injector 102.

The distance of movement may be audibly ascertained by the engagement ofthe contact 40 with the sound producing structures 36 (i.e., ridges orgrooves) on the electronic substrate 24, or by engagement of the contact40 with an equivalent electronic sound producing on the electronicsubstrate 24. The engagement of the contact 40 with the sound producingstructures 36 will make a clicking sound or other audible cue, and theengagement of the contact 40 with the electronic sound producing devicewill make an electronically generated sound or tone. In each case, thesound produced will give an indication as to the length or distance ofmovement of the actuating member 38 relative to the housing 12 and,hence, the corresponding flow rate delivered by the fluid deliverysystem 100.

Additionally, the sound producing structures 36 are raised from orindented sufficiently into the electronic substrate 24 such that theengagement of the contact 40 with the sound producing structures 36provides the operator with tactile feedback indicating the length,distance, or progression of movement of the actuating member 38 relativeto the housing 12 (i.e., depression of the actuating member 38 in thehousing 12). As generally indicated, the producing structures 36 may beformed as grooves, recesses, or indentations in the electronic substrate24. Thus, the operator will experience tactile feedback that correspondsto the flow rate that will be delivered by the fluid delivery system 100due to the engagement of the contact 40 with the sound producingstructures 36.

Further, the biasing assembly 54 associated with the actuator 14 willprovide immediate tactile feedback in the form of increasing resistivepressure as the actuating member 38 is depressed into the housing 12.Thus, the further the actuating member 38 is depressed into the housing12, the more resistive force the operator will feel. The increasingresistance will provide immediate physical feedback that flow rate isincreasing in the fluid path set 108 associated with the patient. Theincreasing resistance intuitively tells the operator that flow rate isincreasing.

An alternative, second embodiment of the hand controller 10 a is shownin FIGS. 5-9. The hand controller 10 a is substantially functionallyidentical to the foregoing embodiment of the hand controller 10. Thehousing 12 a of the hand controller 10 a has the same externalappearance as the housing 12 of the foregoing embodiment of the handcontroller 10, and includes housing sides or portions 20 a, 22 a. Thehousing 12 a is constructed of similar materials as the housing 12 inthe foregoing embodiment. When the housing portions 20 a, 22 a arejoined to enclose the internal components of the hand controller 10 a,the visible components of the hand controller 10 a, including theactuating member 38 a, finger pad 44 a, control button 66 a, and cable16 a have generally the same external appearance as the forgoingembodiment of the hand controller 10. The internal components of thehand controller 10 a have a slightly different configuration andarrangement from the foregoing embodiment of the hand controller 10, andthese differences will now be discussed with reference generally toFIGS. 5-9.

Initially, it is noted that the cable 16 a used in the hand controller10 a is identical to the cable 16 discussed previously. The housingportions 20 a, 22 a also include one or more internal rib structures 23a that provide structural support to the housing portions 20 a, 22 a,and support locations for supporting various internal components of thehand controller 10 a. As with the foregoing embodiment, the ribstructures 23 a are generally adapted to support the internal componentsof the of the hand controller 10 a in housing portion 22 a of thehousing 12 a. However, it will apparent when comparing FIGS. 2 and 5that the arrangement of the rib structures 23 a is formed slightlydifferently from the rib structures 23 discussed previously. In bothcases, however, the rib structures 23, 23 a in housing portions 22, 22 aare generally adapted to support the internal components of the handcontroller 10 a, as indicated.

Housing portion 22 a of the housing 12 a includes posts 204 in place ofbosses 26. The posts 204 are adapted to mate or engage correspondingreceptacles 206 formed internally in housing portion 20 a of the housing12 a. The connection between the posts 204 and receptacles may be acompression friction fit. Thus, the housing portions 20 a, 22 a may bepermanently secured together via a compression fit between the posts 204and receptacles 206, once the internal components of the hand controller10 a have been assembled in place within the housing 12 a.

The electronic substrate 24 a of the hand controller 10 a is analogousin construction and operation to the electronic substrate 24 of thefirst embodiment of the hand controller 10. Thus, the electronicsubstrate 24 a includes the same conductive pattern 32 a and wire holes29 a as found on the electronic substrate 24. However, unlike theprevious electronic substrate 24, the current electronic substrate 24 alacks the sound producing structures 36. Additionally, the holes 25 adefined in the electronic substrate 24 a are now adapted to accept theposts 204 extending from housing portion 22 a of the housing 12 a tomount the electronic substrate 24 a in position within housing portion22 a and within the housing 12 a generally. The hand controller 10 aalso uses an analogous electrical connection between the control button66 a and the electronic substrate 24 a. As with the control button 66discussed previously, the control button 66 a is adapted for a pivotalassociation with the housing 12 a. However, the control button 66 a isnow adapted for pivotal association with housing portion 22 a of thehousing 12 a rather than housing portion 20 a of the housing 12 a, aswas the case in the hand controller 10. The cable 16 a is electricallyconnected to the electronic substrate 24 a by associating the wires 30 aof the cable 16 a with the wire holes 29 a in the electronic substrate24 a.

The sound producing structures 36 a of the hand controller 10 a areprovided in a different location from the first embodiment of the handcontroller 10. Specifically, the sound producing structures 36 a are nowprovided on one of the rib structures 23 a in housing portion 22 a ofthe housing 12 a. The sound producing structures 36 a may again beformed as ridges or grooves. However, the sound producing structures 36a may further be formed as angled indents or recesses in the ribstructure 23 a as shown in FIGS. 5, 6, and 9. If the sound producingstructures 36 a are formed as ridges or similar raised structures, suchraised structures may be formed as angled or pointed tabs on the ribstructure 23 a. Additionally, the “raised” version of the soundproducing structures 36 a may be formed integrally with the ribstructure 23 a, or provided as separate structures secured to the ribstructure 23 a. Additionally, the sound producing structures 36 a may beprovided in any convenient location within the housing 12 a. Forexample, the sound producing structures 36 a may be arranged within thesame vertical plane and spaced in parallel relation to the electronicsubstrate 24 a. As indicated previously, the sound producing structures36 a provide the user with an auditory and tactile indication of theactuation of the hand controller 10 a. The sound producing structures 36a are physically engaged by a portion of the actuator 14 a, as will bediscussed further herein, to produce the auditory and tactileindications to the user. As further indicated previously, the soundproducing structures 36 a may be replaced by a generally equivalentelectronic sound producing device.

The actuator 14 a of the hand controller 10 a has a similar overallexternal appearance to the actuator 14 discussed previously. However,the actuator 14 a is configured to operatively associate with theconductive pattern 32 in a slightly different manner than the actuator14 discussed previously. One difference between the actuator 14 a andthe actuator 14 discussed previously lies in the form of the contact 40a. An additional difference relates to the form and construction of theactuating member 38 a of the actuator 14 a and how the actuating member38 a supports the contact 40 a. A further difference relates to the waythe actuator 14 a interacts with the sound producing structures 36 a nowdisposed in housing portion 22 a of the housing 12 a. A still furtherdifference relates to the location and configuration of the biasingassembly 54 a of the actuator 14 a. Each of the foregoing differencesand others will be discussed in detail herein.

Beginning with the actuating member 38 a, the actuating member 38 aexhibits the same general “plunger” form and operation as the actuatingmember 38 discussed previously. The slide rails 42 a, 43 a of theactuating member 38 a are spaced apart to accept the electronicsubstrate 24 a therebetween. However, the slide rails 42 a, 43 a nolonger define guide tracks 45 for slidably accepting the electronicsubstrate 24 a. Accordingly, the side rails 42 a, 43 a will be referredto hereinafter simply as “rails 42 a, 43 a”. The rails 42 a, 43 a definea generally rectangular-shaped receiving pocket 208 for accommodatingthe electronic substrate 24 a. The rod portion 41 a of the actuatingmember 38 a is formed integrally with the rails 42 a, 43 a in a similarmanner to the actuating member 38 discussed previously. Since theelectronic substrate 24 a is fixedly mounted on the posts 204 when theportions 20 a, 22 a of the housing 12 a are joined together, thereceiving pocket 208 is sized sufficiently to allow the actuating member38 a to move up and down relative to the electronic substrate 24 a(i.e., slidably along the electronic substrate 24 a).

The actuating member 38 a is generally configured to support analternative embodiment or variation of the contact 40 discussedpreviously. The contact 40 described previously is formed generally as aplate-like structure or member and is secured to the actuating member 38with mechanical fasteners 46, 47. The contact 40 included contactfingers 52 for interacting with the electronic substrate 24 and soundproducing structures 36.

In the present embodiment, the actuating member 38 a is also configuredto support the contact 40 a, but the contact 40 a now is in the form ofa contact roller and will be referred to hereinafter as “contact roller40 a”. The contact roller 40 a includes a roller 210 rotatably mountedon an axle 212. The axle 212 is in turn rotatably supported by theactuating member 38 a. In the present embodiment, the actuating member38 a is specifically adapted to rotatably support the contact roller 40a. The roller 210 is constructed of resilient and conductive material,such as conductive rubber. For example, the roller 210 may be a siliconebased extruded elastomer having a silver-copper blend filing. However,the roller 210 may be made of any suitable conductive material, such asmetal and, in particular, aluminum.

To support the contact roller 40 a, the rails 42 a, 43 a of theactuating member 38 a include extended support members 214, 216 adaptedto rotatably support the axle 212. The support members 214, 216 may beintegral, extended portions of the respective rails 42 a, 43 a. Thesupport members 214, 216 define opposing notches or recesses 218 forrotatably supporting the ends of the axle 212. The support members 214,216 further include guide tabs or ramps 220 disposed immediatelyadjacent the notches 218 to guide entry of the ends of the axle 212 intothe notches 218 when the actuator 14 a is assembled.

The support members 214, 216 define longitudinal gaps 222 with distalends 224, 226 of the rails 42 a, 43 a. The longitudinal gaps 222 allowthe respective support members 214, 216 to flex relative to the distalends 224, 226 of the rails 42 a, 43 a when the contact roller 40 a ismounted to the support members 214, 216 and engaged with the electronicsubstrate 24 a. When the actuator 14 a is assembled and mounted in placebetween the housing portions 20 a, 22 a of the housing 12 a, theactuating member 38 a including the rails 42 a, 43 a and support members214, 216 are movable up and down within the housing 12 a in the mannerexplained in detail previously in connection with the hand controller10. However, due to the engagement of the roller 210 with the electronicsubstrate 24 a in the present embodiment, the support members 214, 216will be flexed outward (i.e., generally transversely) a small distancefrom the rails 42 a, 43 a and, more particularly, outward from thedistal ends 224, 226 of the rails 42 a, 43 a. The “flexure” of thesupport members 214, 216 is caused by sizing the distance between theroot of the notches 218 and the surface of the electronic substrate 24 aslightly smaller than the diameter of the roller 210. As a result, whenthe axle 212 is mounted in the notches 218 and the electronic substrate24 a is fixed to the posts 204, the roller 210 through the axle 212 willcause the support members 214, 216 to flex or cantilever away from thedistal ends 224, 226 of the rails 42 a, 43 a. This flexure applies areturn or “back” pressure on the roller 210 through the axle 212. Theback pressure on the roller 210 causes the resilient material of theroller 210 to deform and “mold” into engagement with the conductivepattern 32 a on the electronic substrate 24 a, resulting in a generallyimproved electrical contact between the contact roller 40 a andconductive pattern 32 a. The resiliency of the material forming theroller 210 and applied back pressure allows the roller 210 toaccommodate height variances present in the electrical contacts orcolumns 34 a-e forming the conductive pattern 32 a. However, the backpressure is not significant enough to impede rotation of the roller 210along the surface of the electronic substrate 24 a.

The actuating member 38 a and, by extension, the support members 214,216 and rails 42 a, 43 a are made of a resiliently deformable ordeflectable material such as plastic to allow for the flexure of thesupport members 214, 216. It will be generally understood that the backpressure or “flexure” force applied by the support members 214, 216 willbe proportional to the flexibility of the material forming the actuatingmember 38 a. The support members 214, 216 do not necessarily have to beformed integrally with the rails 42 a, 43 a and could be provided asseparate elements that are secured to the rails 42 a, 43 a.Alternatively, since the support members 214, 216 are generally adaptedto bias the roller 210 into engagement with the electronic substrate 24a, the support members 214, 216 could be replaced by a suitablemechanically equivalent biasing structure associated with the axle 212and roller 210 to bias the roller 210 into engagement with theelectronic substrate 24 a. Such an arrangement could include one or morebiasing elements, such as compression or leaf springs, associated withthe axle 212 to bias the roller 210 into engagement with the electronicsubstrate 24 a.

The contact roller 40 a when biased into engagement with the electronicsubstrate 24 a by the arrangement described hereinabove exerts acontinuous and consistent pressure over the surface of the electronicsubstrate 24 a and, specifically, the conductive pattern 32 a. However,as indicated, the roller 210 is not impeded to a degree that wouldprevent the roller 210 from rotating on the axle 212 and rolling alongthe surface of the electronic substrate 24 a based on inputs from theuser or biasing assembly 54 a to be discussed hereinbelow. As with thecontact 40 discussed previously having contact fingers 52, the roller210 of the contact 40 a allows for selective shorting across theconductive pattern 32 a to allow sequential access to the predetermineddigital values in the conductive pattern 32 a when the actuating member38 a is actuated by a user.

The biasing assembly 54 a is provided in a different location from thebiasing assembly 54 discussed previously, but includes the same generalcomponents as the earlier embodiment of the biasing assembly 54 and isfunctionally identical to the biasing assembly 54 discussed previously.The mandrel 56 a is now formed integrally with the actuating member 38a. The mandrel 56 a is located adjacent and generally parallel to rail42 a and is disposed substantially within housing portion 22 a of thehousing 12 a when the hand controller 10 a is assembled. However, themandrel 56 a may be associated with the actuating member 38 a in anyconvenient location to allow for the biasing of the actuating member 38a to the neutral or no-flow position described previously in connectionwith the hand controller 10. The spring 58 a is associated with themandrel 56 a in a similar manner to the mandrel 56 and spring 58discussed previously. However, as will be clear when viewing FIG. 5, themandrel 56 a no longer engages a ledge formed on one of the ribstructures 23 a, but extends through a recess 228 defined in one of therib structures 23 a in housing portion 22 a of the housing 12 a. Inparticular, the rib structures 23 a in the right portion 12 a generallydefine an internal pocket 230 for receiving both the spring 58 a andmandrel 56 a. The bottom of the internal pocket 230 forms a ledge 232for supporting one end of the spring 58 a. The ledge 232 is similar infunction to the ledge 65 described previously in connection with thehand controller 10. However, in the present embodiment, the spring 58 anow acts between the ledge 232 and an upper cross member 234 of theactuating member 38 a. Thus, when the mandrel 56 a is moved downward inthe internal pocket 230 as the actuating member 38 a is depressed intothe housing 12 a by a user, the compression spring 58 is compressedwithin the internal pocket 230. The compression spring 58 a provides acounteracting biasing force against the downward movement, and biasesthe actuating member 38 a to the neutral or no-flow position discussedpreviously.

The actuating member 38 a further includes an additional structure 236for interacting with the sound producing structures 36 a now providedon/in one of the rib structures 23 a in the right portion 22 a of thehousing 12 a. The “sound producing” structure 236 generally includes onelongitudinal member 238 connected to the cross member 234 of theactuating member 38 a and one transverse member 240 interconnecting thedistal ends 224, 226 of the rails 42 a, 43 a. The transverse member 240provides structural reinforcement to the distal ends 224, 226 of therails 42 a, 43 a.

The longitudinal member 238 includes a raised tab (or detent) 242 thatengages with the sound producing structures 36 a. The tab 242 is angledor pointed to engage the raised, angled ridges or V-shaped indents orgrooves forming the sound producing structures 36 a. The raised ridgesor V-shaped indents or grooves forming the sound producing structures 36a may be formed in a manner to generally correspond to the tab 242. Theengagement of the tab 242 with the sound producing structures 36 a willproduce a distinct “clicking” sound as these elements engage oneanother. This engagement will also be tactilely apparent to the user ofthe hand controller 10 a as the opposing tabs move over one another.Thus, the engagement of the tab 242 with the corresponding soundproducing structures 36 a provides both audible and tactile feedback tothe user of the hand controller 10 a during a fluid injection procedure.Other than the internal differences between the hand controller 10 adiscussed in the forgoing paragraphs, there is substantially nodifference in operation between the two hand controllers 10, 10 a.

As noted earlier in this disclosure, the concept of diluting contrastwith saline is gaining in popularity in the medical imaging industry.For example, a medical practitioner for a diagnostic, interventional, ortherapeutic procedure may be concerned with the amount of contrast mediato be delivered to the patient, for example, if the patient has somepreexisting condition that could lead to contrast-induced nephropathyand other medical complications. While the following discussion relatesto the mixing of contrast and saline this should not be deemed limitingas the fluid delivery system 100 may be used to inject fluids other thancontrast and saline. For example, in certain applications it may bedesirable to “mix” a radiopharmaceutical fluid, for example, with salineand inject this mixture into a patient using the fluid delivery system100. Accordingly, hand controllers 10, 10 a may be adapted to allow theoperator to dilute contrast media (or another fluid) to a point whereradiographic images are still useful but also reduce the overall amountof contrast media delivered. Such a modification to hand controllers 10,10 a may be used in diagnostic, interventional, or therapeuticprocedures so that valuable images are obtained while limiting the totalamount of contrast delivered to the patient which, as indicated, mayhave particular advantage for more distressed patients (diabetics, etc.)undergoing such procedures.

As further indicated previously, such mixing may be real-time and themodified hand control devices 10, 10 a may allow both real-timevariability of flow rate and variability of contrast media/saline mix(or of any two desired fluids). The modified, mixing control devices 10,10 a, to be discussed herein, will interface with automatic fluidinjection or delivery system 100 generally in the same manner describedpreviously and system 100 will act upon the signals outputted by thecontrol device 10, 10 a to operate, for example, in a fully contrastdelivery mode, fully saline delivery mode, or a hybrid mixing modewherein contrast and saline (or any two or more fluids) are concurrentlydelivered to the patient in fixed ratios. For the purposes ofillustration, several mixing control modifications 300 to control device10 a are described herein in connection with FIGS. 10-13. Eachmodification 300 is adapted provide the operator with the ability tocontrol the ratio of contrast to saline via manual control apparatusdesirably provided on the body of the control device 10 a. However, itwill be generally clear that each modification 300 maintains theprevious operational characteristics associated with control device 10a. Similar modifications may be applied to control device 10 if desired.

In a first modification 300 a to control device 10 a shown in FIGS.10A-10C, the ratio of contrast to saline is controlled by a linearpotentiometer 302 a having a slider 304 a. It will be understood thatactuating member 38 a operates in the manner described previously inthis disclosure to control the overall flow rate of fluid delivered byfluid delivery system 100, which may be fully contrast, fully saline, ora mixture thereof. Linear potentiometer 302 a is electrically connectedto electronic substrate 24 a. As is well-known in the electronics field,potentiometers are used to produce a variable amount of resistancedepending on the position of a slider. In the present embodiment, thelinear potentiometer 302 a electrically interfaces with electronicsubstrate 24 a so movement of the slider 304 a produces a range ofoutput signals from electronic substrate 24 a that is outputted viacable 16 a to the fluid delivery system 100 and instructs the same tooperate, for example, in a contrast delivery mode, a saline deliverymode, and a “mixing” mode comprising contrast-saline mixture ratiosdefined by the position of the slider 304 a. Such output signals may becontinuously variable and interpreted continuously by the controlunit(s) of the components of the fluid delivery system 100 and result incontinuously variable changes in the contrast to saline mixture.Alternatively, such output signals may be discretely interpreted by thecontrol unit(s) of the components of the fluid delivery system 100 inthat movement of the slider 304 a provides inputs to the electronicsubstrate 24 a which will yield output signals that result in specifiedor predefined ratios of contrast to saline mixtures to be outputted fromthe fluid delivery system 100. In this latter operational mode, thefluid delivery system 100 and, more particularly, the control unit(s) ofthe fluid delivery system 100 discretely interprets the output signalsfrom the electronic substrate 24 a indicative of the incremental (orcontinuous) movement of the slider 304 a as a specified mixture ratio ofcontrast to saline. In other words, the control unit(s) may interpretincremental (or continuous) movement as requests for incremental ordiscrete changes in contrast-saline mixture. The illustrated slider 304a may extend though a front opening 306 a in housing 12 a so as to beaccessible by the operator's fingers. Housing portions 20 a, 22 a ofhousing 12 a may together define a cavity 308 a adjacent electronicsubstrate 24 a for positioning the linear potentiometer 302 a.

In exemplary operation, movement of the slider 304 a all the way to thelower end of front opening 306 a may result in a delivery of 100%contrast media from fluid delivery system 100 and opposite movement tothe upper end of front opening 306 a may yield 100% saline. Intermediatepositions of slider 304 a between these extremes may yield continuouslyvariable ratios of contrast to saline mixtures or, alternatively,discrete ratios may be defined between these extremes. In like manner tothat described previously, eleven exemplary discrete positions may beprovided between the extremes of 100% contrast and 100% saline with eachincremental or discrete position change resulting in, for example, a 10%change in the ratio mixture. For example, one discrete step or movement“up” by slider 304 a from the lower end of front opening 306 a may yielda 90% contrast and 10% saline mixture. A second discrete step ormovement upward may yield an 80% contrast and 20% saline mixture, and soon. To further clarify, the control unit(s) of the delivery system 100may have stored therein a series of predefined resistance values oflinear potentiometer 302 a which correspond to a variety of differentcontrast saline mixes. Accordingly, as a user continuously moves slider304 a between the lower end of front opening 306 a and the upper end offront opening 306 a, the control unit(s) will only instruct fluiddelivery system 100 to change the ratio of contrast to saline when oneof the predefined resistance values of linear potentiometer 302 a ismet. In this manner, continuous movement of slider 304 a can beconverted to discrete mixture ratios by the control unit(s). Tactileand/or auditory features much like that described in connection withdetent 242 and sound producing structures 36 a may be used to indicateeach discrete change in mixture ratio with each discrete movement of theslider 304 a.

FIGS. 11A-11C illustrate a second modification 300 b to control device10 a wherein the ratio of contrast to saline is controlled by arotational potentiometer 302 b having a rotational dial 304 b. As iswell-known in the electronics field, rotationally potentiometers areused to produce a variable amount of resistance depending on theposition of a shaft 310 b supporting dial 304 b. In the presentembodiment, the rotational potentiometer 302 b interfaces withelectronic substrate 24 a so rotational movement of the dial 304 bproduces a range of output signals from electronic substrate 24 a thatis outputted via cable 16 a to the fluid delivery system 100 andinstructs the same to operate, for example, in a contrast delivery mode,a saline delivery mode, and a “mixing” mode comprising contrast-salinemixture ratios defined by the rotational position of the shaft 310 bsupporting dial 304 b. Such output signals may be continuously variableand interpreted continuously by the control unit(s) of the fluiddelivery system 100 and result in continuously variable changes incontrast to saline mixture. Alternatively, such output signals may bediscretely interpreted by the control unit(s) of the fluid deliverysystem 100 in that rotational movement of the shaft 310 b supportingdial 304 b provides inputs to the electronic substrate 24 a which willyield output signals that result in specified or predefined ratios ofcontrast to saline mixtures to be outputted from the fluid deliverysystem 100. In this latter operational mode, the fluid delivery system100 and, more particularly, the control unit(s) of the fluid deliverysystem 100 interprets the output signals from the electronic substrate24 a indicative of the incremental (or continuous) rotational movementof the shaft 310 b supporting dial 304 b as a specified mixture ratio ofcontrast to saline. In other words, the control unit(s) may interpretincremental or (or continuous) rotational movement as requests forincremental or discrete changes in contrast-saline mixture. Theillustrated dial 304 b may likewise extend though a front opening 306 bin housing 12 a so as to be accessible by the operator's fingers.Housing portions 20 a, 22 a of housing 12 a may again define a cavity308 b adjacent electronic substrate 24 a for positioning the rotationalpotentiometer 302 b.

In exemplary operation, rotational movement of the rotational dial 304 ball the way to one extreme may result in a delivery of 100% contrastmedia from fluid delivery system 100 and opposite rotational movement tothe opposite extreme may yield 100% saline. Intermediate rotationalpositions of the dial 304 b between these extremes may yieldcontinuously variable ratios of contrast to saline mixtures or,alternatively, discrete ratios may be defined between these extremes inlike manner to that described immediately above. To further clarify, thecontrol unit(s) of the delivery system 100 may have stored therein aseries of predefined resistance values of rotational potentiometer 302 bwhich correspond to a variety of different contrast saline mixes.Accordingly, as a user continuously moves dial 304 b in front opening306 b, the control unit(s) will only instruct fluid delivery system 100to change the ratio of contrast to saline when one of the predefinedresistance values of rotational potentiometer 302 b is met. In thismanner, continuous rotational movement of dial 304 b can be converted todiscrete mixture ratios by the control unit(s). Tactile and/or auditoryfeatures much like that described in connection with detent 242 andsound producing structures 36 a may be used to indicate each discretechange in mixture ratio with each discrete movement of the dial 304 b.

FIGS. 12A-12C illustrate a third modification 300 c to control device 10a wherein the ratio of contrast to saline is controlled by a pair ofpush buttons 312 c, 314 c electrically connected to electronic substrate24 a. As is well-known in the electronics field, electrical push buttonsare used to produce electrical inputs to electronic substrates. In thepresent embodiment, an “up” push button 312 c and a “down” push button314 c are provided to interface with electronic substrate 24 a so thatpressing either button (repeatedly or continuously) produces a range ofoutput signals from the electronic substrate 24 a that is outputted viacable 16 a to control unit(s) of the fluid delivery system 100 andinstructs the same to operate, for example, in a contrast delivery mode,a saline delivery mode, and a “mixing” mode comprising contrast-salinemixture ratios defined by the “up” and “down” inputs to push buttons 312c, 314 c. Once again, such output signals may be continuously variableand interpreted continuously by the control unit(s) of the fluiddelivery system 100 and result in continuously variable changes in thecontrast-saline mixture ratios defined by the by the “up” and “down”inputs to push buttons 312 c, 314 c. Alternatively, such output signalsmay be discretely interpreted by the control unit(s) of the fluiddelivery system 100 in that discrete (or continuous depressing) of the“up” and “down” push buttons 312 c, 314 c provides inputs to theelectronic substrate 24 a which will yield output signals that result inspecified or predefined ratios of contrast to saline mixtures to beoutputted from the fluid delivery system 100. In this latter operationalmode, the fluid delivery system 100 and, more particularly, the controlunit(s) of the fluid delivery system 100 interprets the output signalsfrom the electronic substrate 24 a indicative of the discrete orcontinuous depressing of the “up” and “down” push buttons 312 c, 314 cas specified mixture ratios of contrast to saline. In other words, thecontrol unit(s) may interpret incremental or (or continuous) depressingof push buttons 312 c, 314 c as requests for incremental or discretechanges in contrast-saline mixture. The illustrated push buttons 312 c,314 c may extend through respective openings 306 c in housing 12 a so asto be accessible by the operator's fingers. Housing portion 22 a ofhousing 12 a may again define internal support structure for supportingpush buttons 312 c, 314 c in a similar manner to button 66 a discussedpreviously.

In exemplary operation, depressing one or the other of push buttons 312c, 314 c results in changes in the mixture ratio of contrast to saline.For example, if the medical practitioner desires more contrast and lesssaline, he or she may press (either multiple times or with continuouspressure) the “up” push button 312 c which inputs an electrical signalto the electronic substrate 24 a. Electronic substrate 24 a providesoutput signals to the control unit(s) of the fluid delivery system 100indicating that additional contrast is desired. Typically, at somepreselected point in time or after a preselected number of “pushes”, acontrast delivery of 100% contrast media is reached and furtherdepressing of the push button 312 c yields no further effect. In otherwords, depressing push button 312 c continuously or possibly repeatedlysends electrical signals to the electronic substrate 24 a which providesoutput signals to the control unit(s) of the fluid delivery system 100which ultimately determines that the operator desires a 100% contrastevent. Depressing (continuously or intermittently) push button 314 cthereafter results in output signals from the electronic substrate 24 athat saline is now desired. The fluid delivery system 100 responds withan increasing percentage of saline. As noted in the foregoing, theoutput signals may be continuously monitored and responded to by thefluid delivery system 100 thereby resulting in continuously variableratios of contrast to saline mixtures. Alternatively, discrete orcontinuous depressing of the push buttons 312 c, 314 c may result indiscrete ratio changes, such as a 10% incremental change for eachdepression of the respective push buttons 312 c, 314 c, as determined bythe control unit(s) of the fluid delivery system 100. To furtherclarify, the control unit(s) of the delivery system 100 may have storedtherein a series of predefined resistance values of the push buttons 312c, 314 c which correspond to a variety of different contrast salinemixes. Accordingly, as a user intermittently or continuously pushes oneof push buttons 312 c, 314 c, the control unit(s) will only instructfluid delivery system 100 to change the ratio of contrast to saline whenone of the predefined resistance values is met. In this manner,intermittent or continuous depressing of push buttons 312 c, 314 c canbe converted to discrete mixture ratios by the control unit(s). As withthe two previously embodiments, tactile indicators (physical and/oraudible “clicks” or other sensory alerts associated with push buttons312 c, 314 c) may denote each increment change which corresponds to apredetermined mixture ratio.

In one further modification 300 d to control device 10 a shown in FIGS.13A-13C, the ratio of contrast to saline is controlled by anelectromechanical interacting arrangement similar to the contact roller40 a and electronic substrate 24 a discussed previously. In particular,a second electronic substrate 24 d is provided opposite from electronicsubstrate 24 a. Additionally, an actuator 14 d comprising an actuatingstructure 38 d, which is similar to actuating member 38 a, is providedto move relative to electronic substrate 24 d. Actuating member 38 dincludes rails 42 d, 43 d to receive the electronic substrate 24 dtherebetween. Electronic substrate 24 d is associated with housingportion 20 a of housing 12 a in a generally similar manner to the wayelectronic substrate 24 a is associated with housing portion 22 a ofhousing 12 a discussed previously.

In the present embodiment, the actuating member 38 d is configured tosupport a contact roller 40 d similar to contact roller 40 a in themanner discussed previously. The contact roller 40 d includes roller 210d rotationally mounted on an axle 212 d. The axle 212 d is in turnrotationally supported by the actuating member 38 d. To support thecontact roller 40 d, the rails 42 d, 43 d of the actuating member 38 dinclude extended support members 214 d, 216 d adapted to rotationallysupport the axle 212 d. The support members 214 d, 216 d define opposingnotches or recesses 218 d for rotationally supporting the ends of theaxle 212 d. The support members 214 d, 216 d further include guide tabsor ramps 220 d disposed immediately adjacent the notches 218 d to guideentry of the ends of the axle 212 d into the notches 218 d.

The support members 214 d, 216 d define longitudinal gaps 222 d withdistal ends 224 d, 226 d of the rails 42 d, 43 d. The longitudinal gaps222 d allow the respective support members 214 d, 216 d to flex relativeto the distal ends 224 d, 226 d of the rails 42 d, 43 d when the contactroller 40 d is mounted to the support members 214 d, 216 d and engagedwith the electronic substrate 24 d. The actuating member 38 d includes ahandle member 320 d extending laterally from rail 43 d and through aside opening 322 d in housing 12 a defined by the opposing housingportions 20 a, 22 a forming housing 12 a. Handle member 320 d permitsmovement of actuating member 38 d up and down within the housing 12 a inthe manner explained in detail previously. In the manner discussedpreviously, due to the engagement of the roller 210 d with theelectronic substrate 24 d, the support members 214 d, 216 d will beflexed outward (i.e., generally transversely) a small distance from therails 42 d, 43 d and, more particularly, outward from the distal ends224 d, 226 d of the rails 42 d, 43 d. The “flexure” of the supportmembers 214 d, 216 d is caused by sizing the distance between the rootof the notches 218 d and the surface of the electronic substrate 24 dslightly smaller than the diameter of the roller 210 d. This flexureapplies a return or “back” pressure on the roller 210 d through the axle212 d and causes the resilient material of the roller 210 d to deformand “mold” into engagement with conductive pattern 32 d on theelectronic substrate 24 a. Desirably, structure is provided inassociation with rail 42 d which engages, for example frictionally or byintermittent interference engagement, with structure in housing portion20 a such that handle or actuating member 320 d may have physicallydiscrete incremental positions within the side opening 322 d whichcorrespond, for example, with discrete fluid mixture ratios to bedelivered by the fluid delivery system 100 as described further herein.

In view of the foregoing disclosure, it should be clear that electronicsubstrate 24 d comprises a conductive pattern 32 d in the form ofdiscrete digital values much like that described in connection withelectronic substrate 24 a but now these discrete digital values definediscrete mixture ratios of contrast and saline to be delivered by thefluid delivery system 100. Accordingly, the engagement of the contactroller 40 d with the conductive pattern 32 d provides a range ofdiscrete output signals to the control unit(s) of the fluid deliverysystem 100 which is interpreted by the fluid delivery system 100 asdiscrete mixture ratios of contrast and saline (or any two desiredfluid) to be delivered to a patient. Typically, the digital valuesforming the conductive pattern 32 d may be arranged such that thediscrete mixture ratios are linearly proportional to distance ofmovement of the actuating member 38 d. This distance of movement maycorrespond to the handle member 320 d being initially at the top end ofthe side opening 322 d in housing 12 a and being moved to the bottom endof side opening 322 d or vice versa. As with electronic substrate 24 a,the digital values forming conductive pattern 32 d may have any desiredincremental increase between digital values. For example, eachincremental digital value may define a 5%, 10%, 20%, etc. increase andthis corresponds to similar discrete increases (5%, 10%, 20%, etc.) inmixture ratios of contrast and saline delivered by the fluid deliverysystem 100.

As an example, for the purposes of explanation, it may be assumed thatwith the handle member 320 d in a fully “up” position in side opening322 d, a 100% saline delivery will be initiated upon depressing actuator14 a on control device 10 a. As the operator pushes downward on handlemember 320 d, the contact roller 40 d moves downward along conductivepattern 32 d on electronic substrate 24 d and sequentially engages thedigital values forming the conductive pattern 32 d. If it is assumedthat the conductive pattern 32 d is formed by eleven digital values theneach sequential digital value engaged by the contact roller 40 d as aresult of downward movement of the handle member 320 d will increase thepercentage of contrast being delivered by 10%. As suggested previously,physical structure on rail 42 d of actuating member 38 d may engagecorresponding structure in housing portion 12 a to physically andtactilely indicate each incremental position of the handle member 320 dand, thereby, each incremental increase in contrast percentage deliveryin the present example. As the handle member 320 d reaches the bottomend in side opening 322 d, a last incremental position is reached andthis corresponds to a 100% contrast delivery in the present example. Atthis last position, depressing the actuator 14 a on control device 10 awill cause 100% contrast to be delivered and the further the actuator 14a is depressed the greater the flow rate delivered by the fluid deliverysystem 100.

In each of the foregoing mixing modifications 300 a-300 d, it will beclear that the actuator 14 a is used to control the overall flow ratefrom the fluid delivery system 100 whereas each of the variousmodifications 300 a-300 d determines the fluid mixture ratio of contrastto saline. In the fluid delivery system 100, powered injector 102 isused to provide the motive forces to inject contrast media into apatient and a pump device is provided on fluid control module 106 toprovide the motive force to inject saline into the patient. With theforegoing mixing modifications 300 a-300 d, it will be clear thatactuation of actuator 14 a results in discrete changes in overall flowrate from the fluid delivery system 100, whether the fluid beingdelivered is contrast-only, saline-only, or a mixture of these fluids.Actuation of the various devices forming mixing modifications 300 a-300d is intended to instruct the fluid delivery system 100 as to thedesired mixture ratio. This latter actuation may cause the injector 102and/or pump device on the fluid control module 106 to alter the speed ofdelivery of contrast and saline in order to meet the desired mixtureratio and the control unit(s) of the fluid delivery system 100, whetherresiding in the injector 102 and/or fluid control module 106 is capableof responding to both a desired flow rate request (which results fromactuation of actuator 14 a) and a desired mixture ratio request (whichresults from actuation of actuator 14 d). The programming in the controlunit(s) of the fluid delivery system 100 is capable of responding torequests for increased or decreased flow rate and increased or decreasedmixture ratios as desired by the user.

FIG. 14 illustrates an alternative embodiment of fluid delivery system100 a comprising a powered injector 102 a adapted to interface with twosyringes 104 a(1), 104 a(2) which may be fluidly connected to a sourceof contrast media (not shown) and a source of saline (not shown) or anytwo desired fluids. Mixing control device 10 a may be interfaced withinjector 102 a in a similar manner to that described previously inconnection with fluid delivery system 100 described previously andprovides inputs to the control unit, for example, housed in injector 102a so the control inputs to the mixing control device 10 a causes theinjector 102 a to provide desired flow rates and desired contrast-salinemixtures based on the user's inputs to control device 10 a. A suitablemulti-syringe injector for powered injector 102 a is described in U.S.patent application Ser. No. 09/765,498, filed on Jan. 18, 2001, and nowU.S. Pat. No. 7,018,363 assigned to the assignee of the presentapplication, the disclosure of which is incorporated herein by referencein its entirety. Other relevant multi-fluid delivery systems are foundin U.S. patent application Ser. No. 10/159,592, filed on May 30, 2002(published as U.S. 2004/0064041) and in U.S. patent application Ser. No.10/722,370, filed Nov. 25, 2003 (published as U.S. 2005/0113754),assigned to the assignee of the present application, and the disclosuresof which are both incorporated herein by reference.

While the present disclosure was described with reference to exemplaryand alternative embodiments, those skilled in the art may makemodifications and alterations without departing from the scope andspirit of the disclosure. Accordingly, the foregoing detaileddescription is intended to be illustrative rather than restrictive. Thedisclosure is defined by the appended claims, and all changes to thedisclosure that fall within the meaning and range of equivalency of theclaims are to be embraced within their scope.

We claim:
 1. A fluid delivery system for use in medical procedures todeliver multiple injection fluids to a patient, the fluid deliverysystem comprising: an injector for delivering a first of the multipleinjection fluids to the patient; a fluid control device for delivering asecond of the multiple injection fluids to the patient; and a manualcontrol device operatively associated with the injector and the fluidcontrol device, the manual control device comprising: a first actuatorassociated with the manual control device, wherein the first actuatorcontrols discrete mixture ratios of the first and the second of themultiple injection fluids to the patient; and a second actuatorassociated with the manual control device, wherein the second actuatorcontrols a flow rate of the first and the second of the multipleinjection fluids to the patient, wherein actuation of the first actuatorinitiates first output signals to a control unit to deliver the firstand the second of the multiple injection fluids in one of the discretemixture ratios of the first and the second of the multiple injectionfluids to the patient, wherein actuation of the second actuatorinitiates a second output signal to the control unit to control the flowrate of the first and the second of the multiple injection fluids to thepatient.
 2. The fluid delivery system of claim 1, further comprising anelectronic substrate disposed within the manual control device, whereinthe second actuator is adapted to operatively associate with theelectronic substrate when actuated by a user, and wherein the electronicsubstrate comprises a plurality of predetermined digital valuescorresponding to a selected flow rate of a selected ratio of one or moreof the discrete mixture ratios of the first and second of the multipleinjection fluids to be delivered to the patient, such that when thesecond actuator is actuated, the second actuator operatively associateswith the electronic substrate and transmits one or more of the pluralityof predetermined digital values to the control unit.
 3. The fluiddelivery system of claim 2, wherein the second actuator is movablyassociated with the manual control device and the plurality ofpredetermined digital values are arranged such that the selected flowrate increases in linear proportion to a distance the second actuator ismoved.
 4. The fluid delivery system of claim 2, wherein the secondactuator is movably associated with the manual control device and theplurality of predetermined digital values are arranged such that theselected flow rate incrementally increases with a distance the secondactuator is moved.
 5. The fluid delivery system of claim 4, wherein theplurality of predetermined digital values comprise at least a firstdigital value corresponding to no movement of the second actuator and noflow rate from the fluid delivery system, and a last digital valuecorresponding to a maximum movement of the second actuator and a maximumflow rate from the fluid delivery system.
 6. The fluid delivery systemof claim 2, wherein the second actuator is movably associated with themanual control device and comprises an actuating member and a contactroller adapted to operatively associate with a conductive pattern on theelectronic substrate.
 7. The fluid delivery system of claim 1, whereinthe first actuator comprises a potentiometer.
 8. The fluid deliverysystem of claim 7, wherein the potentiometer is one of a linearpotentiometer and a rotational potentiometer.
 9. The fluid deliverysystem of claim 1, wherein the first actuator comprises at least onepush button.
 10. The fluid delivery system of claim 1, wherein themanual control device is operatively associated with the injector andthe fluid control device by a wired cable.
 11. A manual control devicefor controlling a multi-fluid delivery system delivering at least afirst injection fluid and a second injection fluid to a patient, themanual control device comprising: a first actuator associated with themanual control device, wherein the first actuator controls discretemixture ratios of the at least the first injection fluid and the secondinjection fluid; and a second actuator associated with the manualcontrol device, wherein the second actuator controls a flow rate of theat least the first injection fluid and the second injection fluiddelivered by the multi-fluid delivery system; wherein actuation of thefirst actuator initiates first output signals to a control unit of themulti-fluid delivery system to deliver the at least the first injectionfluid and the second injection fluid in one of the discrete mixtureratios of the at least the first injection fluid and the secondinjection fluid, and wherein actuation of the second actuator initiatesa second output signal to the control unit to control the flow rate ofthe at least the first injection fluid and the second injection fluid.12. The control device of claim 11, further comprising an electronicsubstrate disposed within the manual control device, wherein the secondactuator is adapted to operatively associate with the electronicsubstrate when actuated by a user, and wherein the electronic substratecomprises a plurality of predetermined digital values corresponding to aselected flow rate of the at least the first injection fluid and thesecond injection fluid to be delivered to the patient such that when thesecond actuator is actuated, the second actuator operatively associateswith the electronic substrate and transmits one or more of the pluralityof predetermined digital values to the control unit.
 13. The controldevice of claim 12, wherein the second actuator is movably associatedwith the manual control device and the plurality of predetermineddigital values are arranged such that the selected flow rate of the atleast the first injection fluid and the second injection fluid increasesin linear proportion to a distance the second actuator is moved.
 14. Thecontrol device of claim 12, wherein the second actuator is movablyassociated with the manual control device and the plurality ofpredetermined digital values are arranged such that the selected flowrate of the at least the first injection and the second injection fluidincrementally increases with a distance the second actuator is moved.15. The control device of claim 14, wherein the plurality ofpredetermined digital values comprise at least a first digital valuecorresponding to no movement of the second actuator and no flow ratefrom the multi-fluid delivery system, and a last digital valuecorresponding to a maximum movement of the second actuator and a maximumflow rate from the mufti-fluid delivery system.
 16. The control deviceof claim 12, wherein the second actuator is movably associated with themanual control device and comprises an actuating member and a contactroller adapted to operatively associate with a conductive pattern on theelectronic substrate.
 17. The control device of claim 11, wherein thefirst actuator comprises a potentiometer.
 18. The control device ofclaim 17, wherein the potentiometer is one of a linear potentiometer anda rotational potentiometer.
 19. The control device of claim 11, whereinthe first actuator comprises at least one push button.
 20. The controldevice of claim 11, wherein the manual control device is operativelyassociated with the multi-fluid delivery system by a wired cable.